Manufacturing Specifications. All Clinical Materials and commercial supplies of Product shall be manufactured in accordance with the specifications determined by MacroGenics and all Applicable Laws and Regulations.
Manufacturing Specifications. The Manufacture of all Xxxxxx Products during the term of this Agreement shall be the responsibility of DURA. DURA shall manufacture, or cause its subcontractor to manufacture, the Xxxxxx Products under this Agreement in compliance in all material respects with all requirements of applicable laws and regulations and all applicable good manufacturing practices, as prescribed from time to time by the FDA and other applicable worldwide regulatory authorities, using the specifications, manufacturing methods and formulae as agreed upon by DURA and Xxxxxx Corp. II in writing.
Manufacturing Specifications. Licensee shall manufacture all of the Licensee Products that include the Licensed Technology consistent with standards of high quality and design, and Licensee shall exercise its commercially reasonable efforts to consult and cooperate with Licensor at all times in connection with the manufacture of such Licensee Products. In that regard, as early as possible, and in any event prior to the commencement of distribution of each Licensee Product, Licensee shall provide to Licensor pre-distribution versions of each Licensee Product. Licensee agrees that Licensor shall have the right to test and evaluate all Licensee Products which use Licensed Technology to confirm that such Licensee Products conform to the specifications to be developed by Licensee and Licensor pursuant to Section 5.2 hereof. In the event that Licensor determines that any such Licensee Products do not meet such specifications, Licensor shall immediately notify Licensee thereof and Licensee shall use all commercially reasonable efforts to modify such Licensee Products to meet such specifications.
Manufacturing Specifications. All Study Materials and commercial supplies of Product shall be manufactured in accordance with the specifications (i) determined by MacroGenics, (ii) subject to Section 5.3, consistent with those Territory specific specifications required by the applicable Regulatory Authority in the Territory provided by Zai to MacroGenics in writing, and (iii) in compliance with all regulatory requirements and all Applicable Laws and Regulations, as further set forth in the supply agreements and related quality agreements.
Manufacturing Specifications. The furniture to be manufactured by the Buyer shall be made in accordance with the specifications and drawings attached hereto and signed by the parties. Any unauthorized change in such specifications by the Seller may be rejected by the Buyer in its own right. In case of rejection of any or all the furniture by the Buyer due to change is specifications no payment shall be made by the Buyer.
Manufacturing Specifications. Prior to the time at which Dainippon shall place its first purchase order for Bulk Drug Substance hereunder, the Parties shall agree upon the Manufacturing Specification.
Manufacturing Specifications. Anabolic shall manufacture the Products according to the manufacturing batch records, vendor/supplier, and quality control specifications provided by Twinlab, including amounts, procedures and the raw material, finished goods and analytical testing requirements for the manufacture of the Products, which specifications shall, unless amended by Twinlab in writing, be consistent with the specifications for the Products utilized by Twinlab as of the Effective Date and delivered by Twinlab to Anabolic upon the execution of this Agreement (the "SPECIFICATIONS"). Anabolic shall test each finished Product lot produced to assure compliance with the Specifications in accordance with the testing protocol set forth in the Specifications and shall produce, upon Twinlab's reasonable request, which request shall not be unreasonably denied, a copy of the actual test results for verification, including any batch records.
Manufacturing Specifications. All clinical and commercial supplies of Collaboration Molecules and Collaboration Product supplied by MacroGenics shall be manufactured in accordance with the specifications (i) determined by MacroGenics, (ii) subject to Section 8.1(d), consistent with those specifications required by the applicable Regulatory Authority in the Territory provided by Zai to MacroGenics in writing, and (iii) in compliance with all regulatory requirements and all Applicable Laws and Regulations, as further set forth in the supply agreements and related quality agreements.
Manufacturing Specifications. Products shall be manufactured and supplied in accordance with the Manufacturing Specifications and Applicable Regulations;
Manufacturing Specifications. (A) Seller shall manufacture the Cosmetics Products in strict accordance with Buyer's specifications, and such revisions, accepted by Seller, as may be made during the period of this Agreement. The product to be produced shall be merchantable quality.
